Single Ascending Dose Study of MK-1092 in Healthy Partici... | NCT03170544 | Trialant
NCT03170544
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 15, 2019Actual
Enrollment
69Actual
Phase
Phase 1
Conditions
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Interventions
MK-1092, 4.0 nmol/kg
MK-1092, 8.0 nmol/kg
MK-1092, 16 nmol/kg
MK-1092, 32 nmol/kg
MK-1092, 64 nmol/kg
Glargine 3.0 nmol/kg
Lispro 1.2 nmol/kg
Placebo to glargine
Placebo to MK-1092
Dextrose
Insulin
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03170544
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1092-001
Secondary IDs
ID
Type
Description
Link
MK-1092-001
Other Identifier
Merck protocol number
Brief Title
Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)
Official Title
A Single Ascending Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1092 in Healthy Subjects, Subjects With Type 1 Diabetes Mellitus, and Subjects With Type 2 Diabetes Mellitus.
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 16, 2017Actual
Primary Completion Date
Nov 8, 2018Actual
Completion Date
Nov 8, 2018Actual
First Submitted Date
May 26, 2017
First Submission Date that Met QC Criteria
May 26, 2017
First Posted Date
May 31, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Oct 10, 2019
Results First Submitted that Met QC Criteria
Nov 14, 2019
Results First Posted Date
Nov 15, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 14, 2019
Last Update Posted Date
Nov 15, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an active- and placebo-controlled, single-site, four-part trial of MK-1092 in healthy adult participants, in participants with type 1 diabetes mellitus (T1DM), and in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis for this study is that at a dose with sufficient safety, the mean maximal glucose infusion rate (GIRmax) after single subcutaneous (SC) administration of MK-1092 in adult participants with T1DM is within an acceptable range. (Part 3)
Detailed Description
There will be 4 parts in this study. In Part 1, healthy adult participants will be randomized to receive blinded MK-1092 subcutaneously (SC) or glargine SC, as a single dose under the euglycemic clamp. Once a safe and tolerated dose that achieves GIRmax is identified in Part 1, Part 2 will start. In Part 2, 4 different healthy adult participants will be enrolled in a single panel and receive open-label MK-1092 SC as a single dose under the euglycemic clamp and also receive an intravenous infusion of Humalog®. In Part 3, adult participants with T1DM will be randomized to receive blinded MK-1092 SC or insulin glargine SC, as a single dose under the euglycemic clamp. Part 4 includes a 3-period (Periods 1, 2, and 3) design that will explore up to 3 single subcutaneous doses of MK-1092 or insulin glargine in participants with Type 2 diabetes mellitus.
Conditions Module
Conditions
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1, MK-1092, 4.0 nmol/kg
Experimental
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Drug: MK-1092, 4.0 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Part 1, MK-1092, 8.0 nmol/kg
Experimental
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Drug: MK-1092, 8.0 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Part 1, MK-1092, 16 nmol/kg
Experimental
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Drug: MK-1092, 16 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Part 1, MK-1092, 32 nmol/kg
Experimental
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Drug: MK-1092, 32 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Part 1, MK-1092, 64 nmol/kg
Experimental
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-1092, 4.0 nmol/kg
Drug
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Part 1, MK-1092, 4.0 nmol/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
Up to 112 days
Number of Participants Who Discontinued the Study Due to an AE
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
Up to 58 days
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 1 Diabetes Mellitus (T1DM) (Part 3)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and the same treatment (same dose of glargine) received.
Up to approximately 24 hours post-dose
Secondary Outcomes
Measure
Description
Time Frame
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Subject Inclusion Criteria
All participants
Be a healthy male, or healthy female participant (excluding diabetes mellitus in Part 3 participants) of non-child bearing potential. A female non-child bearing potential is one who is postmenopausal without menses for at least 1 year or whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation.
Be judged to be in good health based on medical history, physical exam, vital sign measurements, electrocardiogram (ECG) and laboratory safety tests
Have adequate venous access to support execution of trial procedures
For Parts 1 and 2 (Healthy adult participants)
Healthy male and female participants between the ages of 18 and 50 years (inclusive)
Have a Body Mass Index (BMI) ≥18.5 kg/m^2 and ≤28.0 kg/m^2 at screening
Have fasting blood glucose values at screening must be <100 mg/dL
Be a non-smoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months.
For Part 3 (Adult participants with T1DM):
Be male, or female of non-childbearing potential between 18 to 60 years of age
Have a diagnosis of T1DM as defined by standard diagnostic criteria for ≥12 months at time of the pretrial (screening) visit
Have a BMI ≥18.5 kg/m^2 and ≤32 kg/m^2 at screening.
Be on stable doses of basal insulin over the 2-week period prior to screening and over the 2 weeks prior to dosing
Have a total daily insulin requirement (basal plus prandial) of ≤1.2 units/kg at screening
Have a hemoglobin A1C (HbA1c) ≤10% at the screening visit.
Be a non-smoker or smoker who uses no more than 5 cigarettes or equivalent (e.g., e-cigarettes) per day over the prior 3-month period also may be enrolled (at the discretion of the investigator).
Have a serum C-peptide concentration ≤0.7 ng/mL with a concurrent plasma glucose >90 mg/dL at screening or anytime within 24 weeks prior to screening.
For Part 4 (Adult participants with T2DM):
Diagnosis of T2DM as defined by standard diagnostic criteria for ≥12 months at time of pretrial screening.
Have a BMI ≥18.5 kg/m2 and ≤35.0 kg/m^2 at screening. BMI = mass (kg)/height (m)^2.
Have a hemoglobin A1C (HbA1c) ≥6.5% and ≤10.0%.
T2DM participants are not required to have been on insulin. If using insulin as background therapy, subjects should have a total daily insulin requirement of ≤1.2 units/kg, and have been on stable doses of basal insulin over the 2-week period prior to screening and over the 2 weeks prior to dosing.
Be a non-smoker or smoker who uses no greater than 5 cigarettes or equivalent (e.g., e-cigarettes) daily over the prior 3-month period.
Subject Exclusion Criteria
All participants
Is mentally or legally incapacitated
Has a history of clinically significant endocrine (excluding diabetes mellitus in Part 3 participants), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Has a systolic blood pressure (SBP) ≥140 mm Hg and/or a diastolic blood pressure (DBP) ≥90 mm Hg at screening.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) at screening.
Has a history of cancer (malignancy) Exceptions: (1) Participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) Participants with other malignancies which have been successfully treated ≥10 years prior to the pretrial (screening) visit
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
Has participated in another investigational trial within 4 weeks.
Has been randomized to, and received MK-5160 in prior clinical studies.
Has a QTcF interval >450 msec, has a history of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of Long QT Syndrome).
Has uncorrected hypokalemia
Has uncorrected hypomagnesemia
Is taking concomitant medications that prolong the QT/QTc interval.
Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of trial drug, throughout the trial, until the post-trial visit.
Has had a vaccination within 12 weeks of the pretrial visit.
Consumes greater than 3 glasses of alcoholic beverages per day.
Consumes excessive amounts, defined as greater than 6 servings caffeinated beverages per day.
Is currently a regular or recreational user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months
Has used systemic (intravenous, oral, inhaled) glucocorticoids within 3 months of screening or is anticipated to require treatment with systemic glucocorticoids during study participation.
For Part 1 and Part 2 (Healthy Adult Participants)
- Has an estimated creatinine clearance of <90 mL/min based on Cockcroft-Gault equation
For Part 3 (Adult participants with T1DM):
Has a history of diabetic ketoacidosis in the last 6 months prior to screening.
Has an estimated creatinine clearance of <60 mL/min based on the Cockcroft-Gault equation at screening
Has the diagnosis of hypoglycemia unawareness, or has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 6 months prior to dosing.
Has other major medical problems requiring medication (i.e., history of myocardial infarction (MI), hypercholesterolemia).
Has a known history of celiac disease or significant food allergy, at the discretion of the investigator and Sponsor.
Has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in recombinant human insulin, or to any E.coli-derived drug product.
For Part 4 (Adult participants with T2DM):
Participant has an estimated creatinine clearance of <60 mL/min based on the Cockcroft-Gault equation.
Has a history of diabetic ketoacidosis in the last 6 months prior to screening.
Has the diagnosis of hypoglycemia unawareness, or has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 6 months prior to dosing.
Has a known history of celiac disease or significant food allergy, at the discretion of the Investigator and Sponsor.
Has been treated with a thiazolidinedione or injectable non-insulin anti-diabetic therapy within the past three months prior to dosing.
Has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in regular human insulin, or to any E.coli-derived drug product.
Walford GA, Duncan KE, Hernandez M, Vaddady P, Hompesch M, Morrow L, Stoch SA. A Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Insulin Dimer. Clin Pharmacol Ther. 2022 Jul;112(1):125-132. doi: 10.1002/cpt.2607. Epub 2022 May 3.
This was a 4-part study, participants received MK-1092 or glargine: Part 1 - healthy adult participants; Part 2, healthy adult participants received MK-1092 and also insulin lispro (Humalog®); Part 3 - adult participants with Type 1 diabetes mellitus; Part 4 had 3 periods (Periods 1, 2, and 3), participants with Type 2 diabetes mellitus.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
FG001
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
Periods
Title
Milestones
Reasons Not Completed
Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Aug 21, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: MK-1092, 64 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Part 1, Glargine, 3.0 nmol/kg
Active Comparator
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Drug: Glargine 3.0 nmol/kg
Drug: Placebo to MK-1092
Other: Dextrose
Part 2, MK-1092, 8.0 nmol/kg + lispro, 1.2 nmol/kg
Experimental
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + lispro (Humalog®), 1.2 nmol/kg, as a single dose, in healthy participants
Drug: MK-1092, 8.0 nmol/kg
Drug: Lispro 1.2 nmol/kg
Other: Dextrose
Part 3, MK-1092, 8.0 nmol/kg
Experimental
MK-1092, (8.0 nmol/kg based on Part 1), SC, in participants with T1DM.
Drug: MK-1092, 8.0 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Biological: Insulin
Part 3, MK-1092, 32 nmol/kg
Experimental
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
Drug: MK-1092, 32 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Biological: Insulin
Part 3, Glargine, 3.0 nmol/kg
Active Comparator
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
Drug: Glargine 3.0 nmol/kg
Drug: Placebo to MK-1092
Other: Dextrose
Biological: Insulin
Part 4, MK-1092, 32 nmol/kg
Experimental
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T2DM
Drug: MK-1092, 32 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Biological: Insulin
Part 4, MK-1092, 16 nmol/kg
Experimental
MK-1092, 16 nmol/kg, SC, as a single dose, in participants with T2DM
Drug: MK-1092, 16 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Biological: Insulin
Part 4, MK-1092, 64 nmol/kg
Experimental
MK-1092, 64 nmol/kg, SC, as a single dose, in participants with T2DM
Drug: MK-1092, 64 nmol/kg
Drug: Placebo to glargine
Other: Dextrose
Biological: Insulin
Part 4, Glargine, 3.0 nmol/kg
Active Comparator
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T2DM
Drug: Glargine 3.0 nmol/kg
Drug: Placebo to MK-1092
Other: Dextrose
Biological: Insulin
MK-1092, 8.0 nmol/kg
Drug
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Part 1, MK-1092, 8.0 nmol/kg
Part 2, MK-1092, 8.0 nmol/kg + lispro, 1.2 nmol/kg
Part 3, MK-1092, 8.0 nmol/kg
MK-1092, 16 nmol/kg
Drug
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Part 1, MK-1092, 16 nmol/kg
Part 4, MK-1092, 16 nmol/kg
MK-1092, 32 nmol/kg
Drug
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Part 1, MK-1092, 32 nmol/kg
Part 3, MK-1092, 32 nmol/kg
Part 4, MK-1092, 32 nmol/kg
MK-1092, 64 nmol/kg
Drug
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Part 1, MK-1092, 64 nmol/kg
Part 4, MK-1092, 64 nmol/kg
Glargine 3.0 nmol/kg
Drug
Glargine 3.0 nmol/kg, SC, as a single dose
Part 1, Glargine, 3.0 nmol/kg
Part 3, Glargine, 3.0 nmol/kg
Part 4, Glargine, 3.0 nmol/kg
Lispro 1.2 nmol/kg
Drug
Lispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting ~12 hours after MK-1092 administration.
Part 2, MK-1092, 8.0 nmol/kg + lispro, 1.2 nmol/kg
Humalog®
Placebo to glargine
Drug
Placebo to glargine, SC, as a single dose
Part 1, MK-1092, 16 nmol/kg
Part 1, MK-1092, 32 nmol/kg
Part 1, MK-1092, 4.0 nmol/kg
Part 1, MK-1092, 64 nmol/kg
Part 1, MK-1092, 8.0 nmol/kg
Part 3, MK-1092, 32 nmol/kg
Part 3, MK-1092, 8.0 nmol/kg
Part 4, MK-1092, 16 nmol/kg
Part 4, MK-1092, 32 nmol/kg
Part 4, MK-1092, 64 nmol/kg
Placebo to MK-1092
Drug
Placebo to MK-1092, SC, as a single dose
Part 1, Glargine, 3.0 nmol/kg
Part 3, Glargine, 3.0 nmol/kg
Part 4, Glargine, 3.0 nmol/kg
Dextrose
Other
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 1, Glargine, 3.0 nmol/kg
Part 1, MK-1092, 16 nmol/kg
Part 1, MK-1092, 32 nmol/kg
Part 1, MK-1092, 4.0 nmol/kg
Part 1, MK-1092, 64 nmol/kg
Part 1, MK-1092, 8.0 nmol/kg
Part 2, MK-1092, 8.0 nmol/kg + lispro, 1.2 nmol/kg
Part 3, Glargine, 3.0 nmol/kg
Part 3, MK-1092, 32 nmol/kg
Part 3, MK-1092, 8.0 nmol/kg
Part 4, Glargine, 3.0 nmol/kg
Part 4, MK-1092, 16 nmol/kg
Part 4, MK-1092, 32 nmol/kg
Part 4, MK-1092, 64 nmol/kg
Glucose
Insulin
Biological
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Part 3, Glargine, 3.0 nmol/kg
Part 3, MK-1092, 32 nmol/kg
Part 3, MK-1092, 8.0 nmol/kg
Part 4, Glargine, 3.0 nmol/kg
Part 4, MK-1092, 16 nmol/kg
Part 4, MK-1092, 32 nmol/kg
Part 4, MK-1092, 64 nmol/kg
Up to approximately 24 hours post-dose
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 2 Diabetes Mellitus (T2DM) (Part 4)
The GIRmax, following administration of MK-1092 SC or glargine SC, was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. For Part 4, a linear mixed effects model containing a fixed effect for treatment (MK-1092, Glargine), a nested effect from participants within treatment, an interaction between treatment and period (treatment by period: Period = Period 1, 2, 3) and a random effect due to participants was used. MK-1092 was administered to a single cohort of participants in Periods 1, 2, and 3. Glargine was administered to a single cohort of participants as 3.0 nmol/kg SC in Periods 1, 2, and 3.
Up to approximately 24 hours post-dose
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 1 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Up to approximately 24 hours post-dose
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T1DM (Part 3)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 3 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Up to approximately 24 hours post-dose
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T2DM (Part 4)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 4 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI were based on a linear mixed effects model containing a fixed effect for treatment (MK, Glargine), period (Period 1, Period 2 and Period 3), a nested effect from participants within treatment, and interaction between treatment and period. MK-1092 or glargine was administered to a single cohort of participants in Periods 1, 2, and 3.
Up to approximately 24 hours post-dose
Maximal Plasma MK-1092 Concentration (Cmax) Parts 1 and 3
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Parts 1 and 3
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Rate of Plasma Drug Removal (CL/F) MK-1092 Parts 1 and 3
CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Parts 1 and 3
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Parts 1 and 3
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Maximal Plasma MK-1092 Concentration (Cmax) Part 4
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Part 4
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Rate of Plasma Drug Removal (CL/F) MK-1092 Part 4
CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Part 4
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Part 4
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Maximal Plasma Insulin Glargine Concentration (Cmax) Parts 1 and 3
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Parts 1 and 3
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and had sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Parts 1 and 3
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Parts 1 and 3
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Maximal Plasma Insulin Glargine Concentration (Cmax) Part 4
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Part 4
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Part 4
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]
Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Part 4
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
FG002
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
FG003
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
FG004
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
FG005
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
FG006
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092 8 nmol/kg SC+ Insulin Lipro (Humalog®) 1.2 nmol/kg IV, as a single dose under the euglycemic clamp in healthy participants
FG007
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
FG008
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092 SC 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
FG009
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
FG010
Part 4 (T2DM) Glargine
Glargine, SC, 3.0 nmol/kg, as a single dose in Periods 1, 2, and 3 under the euglycemic clamp in participants with T2DM
FG011
Part 4 (T2DM) MK-1092
MK-1092, SC, 32-, 16-, and 64 nmol/kg in Periods 1, 2, and 3, respectively, as a single dose under the euglycemic clamp in participants with T2DM
FG00010 subjects
FG0016 subjects
FG0026 subjects
FG0037 subjects
FG0046 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0009 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0074 subjects
FG0086 subjects
FG0096 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 4
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0103 subjects
FG0116 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
This analysis set included all randomized and treated participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
BG001
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
BG002
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
BG003
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
BG004
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
BG005
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
BG006
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Humalog
MK-1092 8 nmol/kg SC+ Insulin Lipro (Humalog®) 1.2 nmol/kg IV, as a single dose under the euglycemic clamp in healthy participants
BG007
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
BG008
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092 8 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
BG009
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
BG010
Part 4 (T2DM) Glargine
Glargine, SC, 3.0 nmol/kg, as a single dose in Periods 1, 2, and 3 under the euglycemic clamp in participants with T2DM
BG011
Part 4 (T2DM) MK-1092
MK-1092, SC, 32-, 16-, and 64 nmol/kg in Periods 1, 2, and 3, respectively, as a single dose under the euglycemic clamp in participants with T2DM
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0016
BG0026
BG0036
BG0046
BG0056
BG0064
BG0074
BG0086
BG0096
BG0103
BG0116
BG01269
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00034.3± 8.5
BG00137.5± 12.0
BG00233.5± 9.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
The analysis population included all participants who received at least one dose of the investigational drug. Post-trial adverse events were pooled across treatment groups in each part of the study.
Posted
Count of Participants
Participants
Up to 112 days
ID
Title
Description
OG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG006
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
OG007
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
OG008
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
OG009
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
OG010
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
OG011
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
OG012
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
OG013
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
OG014
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
OG015
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
OG016
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG017
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG018
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG019
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
Units
Counts
Participants
OG00010
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0024
OG003
Primary
Number of Participants Who Discontinued the Study Due to an AE
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
The analysis population included all participants who received at least one dose of the investigational drug. Post-trial adverse events were pooled across treatment groups in each part of the study.
Posted
Count of Participants
Participants
Up to 58 days
ID
Title
Description
OG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
Secondary
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
The analysis population included participants in Part 1 who complied with the protocol sufficiently to ensure that these data likely exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.
Posted
Mean
95% Confidence Interval
mg/kg/min
Up to approximately 24 hours post-dose
ID
Title
Description
OG000
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
Primary
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 1 Diabetes Mellitus (T1DM) (Part 3)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and the same treatment (same dose of glargine) received.
The analysis population included participants in Part 3 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.
Posted
Mean
95% Confidence Interval
mg/kg/min
Up to approximately 24 hours post-dose
ID
Title
Description
OG000
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with Type 1 diabetes mellitus
OG001
Part 3 (T1DM) MK-1092 32 Nmol/kg
Secondary
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 2 Diabetes Mellitus (T2DM) (Part 4)
The GIRmax, following administration of MK-1092 SC or glargine SC, was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. For Part 4, a linear mixed effects model containing a fixed effect for treatment (MK-1092, Glargine), a nested effect from participants within treatment, an interaction between treatment and period (treatment by period: Period = Period 1, 2, 3) and a random effect due to participants was used. MK-1092 was administered to a single cohort of participants in Periods 1, 2, and 3. Glargine was administered to a single cohort of participants as 3.0 nmol/kg SC in Periods 1, 2, and 3.
The analysis population included participants in Part 4 who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Mean
95% Confidence Interval
mg/kg/min
Up to approximately 24 hours post-dose
ID
Title
Description
OG000
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG001
Secondary
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 1 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
The analysis population included participants in Part 1 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.
Posted
Mean
95% Confidence Interval
mg/kg/min
Up to approximately 24 hours post-dose
ID
Title
Description
OG000
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
Secondary
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T1DM (Part 3)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 3 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and same treatment (same dose of glargine) received.
The analysis population included participants in Part 3 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, absence of major protocol deviations. The glargine treatment group was pooled (n=2 participants per panel).
Posted
Mean
95% Confidence Interval
mg/kg/min
Up to approximately 24 hours post-dose
ID
Title
Description
OG000
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Secondary
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T2DM (Part 4)
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 4 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI were based on a linear mixed effects model containing a fixed effect for treatment (MK, Glargine), period (Period 1, Period 2 and Period 3), a nested effect from participants within treatment, and interaction between treatment and period. MK-1092 or glargine was administered to a single cohort of participants in Periods 1, 2, and 3.
The analysis population included participants in Part 4 who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Mean
95% Confidence Interval
mg/kg/min
Up to approximately 24 hours post-dose
ID
Title
Description
OG000
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
Secondary
Maximal Plasma MK-1092 Concentration (Cmax) Parts 1 and 3
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
Secondary
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Parts 1 and 3
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Parts 1 & 3 who received MK-1092 and complied with the protocol (exposure to treatment, availability of measurements, absence of major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 nmol/kg group, 5 participants were excluded (insufficient terminal phase data).
Posted
Geometric Mean
Geometric Coefficient of Variation
nM*hr
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Secondary
Rate of Plasma Drug Removal (CL/F) MK-1092 Parts 1 and 3
CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Parts 1 & 3 who received MK-1092 and complied with the protocol (exposure to treatment, availability of measurements, absence of major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 nmol/kg group, 5 participants were excluded (insufficient terminal phase data).
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Secondary
Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Parts 1 and 3
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only.
The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Median
Full Range
Hours
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
Secondary
Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Parts 1 and 3
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol (treatments, measurements, major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 and 64 nmol/kg groups, 5 and 1 participants, respectively, were excluded (insufficient terminal phase data).
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Secondary
Maximal Plasma MK-1092 Concentration (Cmax) Part 4
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG001
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG002
Part 4 (T2DM) MK-1092 64 Nmol/kg (Period 3)
Secondary
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Part 4
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM*hr
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG001
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG002
Secondary
Rate of Plasma Drug Removal (CL/F) MK-1092 Part 4
CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Parts 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG001
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG002
Secondary
Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Part 4
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.
The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Median
Full Range
Hours
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG001
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG002
Part 4 (T2MD) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
Secondary
Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Part 4
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG001
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG002
Secondary
Maximal Plasma Insulin Glargine Concentration (Cmax) Parts 1 and 3
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol sufficiently so that the data exhibited effects of treatment. One participant (Part 1) was excluded (no quantifiable glargine concentration). Data across panels were pooled for Parts 1 and 3.
Posted
Geometric Mean
Geometric Coefficient of Variation
pg/mL
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
Secondary
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Parts 1 and 3
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and had sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol sufficiently so that the data exhibited the effects of treatment. Two participants in Part 1 and 1 in Part 3 were excluded due to insufficient terminal phase data. Data across panels were pooled for Parts 1 and 3.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*pg/mL
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
Secondary
Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Parts 1 and 3
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol so that data likely exhibited effects of treatment. One participant (Part 1) was excluded (no quantifiable glargine concentration). Data across panels were pooled for Parts 1 and 3.
Posted
Median
Full Range
Hours
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG001
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Secondary
Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Parts 1 and 3
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
The analysis population included participants in Parts 1 and 3 who received glargine and sufficiently complied with the protocol so that the data exhibited the effects of treatment. Two participants excluded in Part 1 and 1 participant excluded in Part 3 due to insufficient terminal phase data. Data across panels were pooled for Parts 1 and 3.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
Secondary
Maximal Plasma Insulin Glargine Concentration (Cmax) Part 4
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Part 4 who received glargine and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Geometric Mean
Geometric Coefficient of Variation
pg/mL
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
OG001
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
OG002
Secondary
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Part 4
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Part 4 who received glargine and complied with the protocol (exposure to treatment, availability of measurements, major protocol deviations) so that data exhibited effects of treatment. Five participants (Period 1:1; Period 2:2; Period 3:2) were excluded due to insufficient terminal phase data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*pg/mL
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)
ID
Title
Description
OG000
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
OG001
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
Secondary
Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Part 4
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.
The analysis population included participants in Part 4 who received glargine and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Posted
Median
Full Range
Hr
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]
ID
Title
Description
OG000
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
OG001
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
OG002
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Secondary
Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Part 4
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
The analysis population included participants in Part 4 who received glargine and complied with the protocol (exposure to treatment, availability of measurements, major protocol deviations) so that data exhibited effects of treatment. Five participants (Period 1:1; Period 2:2; Period 3:2) were excluded due to insufficient terminal phase data.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]
ID
Title
Description
OG000
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
OG001
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
Time Frame
Up to 112 days
Description
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
0
10
0
10
1
10
EG001
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
0
6
0
6
1
6
EG002
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
0
6
0
6
4
6
EG003
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
0
6
0
6
3
6
EG004
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
0
6
0
6
3
6
EG005
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
0
6
0
6
2
6
EG006
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1091 as a single dose under the euglycemic clamp in healthy adults in the Post-trial period
0
40
0
40
0
40
EG007
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
0
4
0
4
3
4
EG008
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-trial
MK-1092, 8.0 nmol/kg selection based on Part 2 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
0
4
0
4
1
4
EG009
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine 3.0 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
0
4
0
4
2
4
EG010
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092 8.0 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
0
6
0
6
6
6
EG011
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 32 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
0
6
0
6
5
6
EG012
Part 3 (T1DM) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
0
16
0
16
2
16
EG013
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine 3.0 nmol/kg, SC, as a single dose under euglycemic clamp in participants with T1DM in Period 1
0
3
0
3
3
3
EG014
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
0
3
0
3
1
3
EG015
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
0
3
0
3
0
3
EG016
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
0
6
0
6
3
6
EG017
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
0
6
0
6
3
6
EG018
Part 4 (T2DM) 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg dose as a single dose under euglycemic clamp in participants with T2DM
0
6
0
6
4
6
EG019
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under euglycemic clamp in participants with T2DM in the Post-trial period
0
9
0
9
0
9
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected40 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected6 at risk
EG0180 events0 affected6 at risk
EG0190 events0 affected9 at risk
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Administration site extravasation
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Application site dermatitis
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0023 events3 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysfunctional uterine bleeding
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pseudohypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Hormones, Hormone Substitutes, and Hormone Antagonists
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D061266
Insulin, Short-Acting
D006601
Hexoses
D009005
Monosaccharides
D000073893
Sugars
D002241
Carbohydrates
D011384
Proinsulin
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0074 subjects
FG0086 subjects
FG0096 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0103 subjects
FG0116 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
34.2
± 8.7
BG00435.2± 9.3
BG00535.0± 5.7
BG00645.3± 2.6
BG00739.0± 12.0
BG00834.2± 10.0
BG00940.0± 10.4
BG01052.0± 9.6
BG01151.5± 4.3
BG01238.3± 10.1
0
BG0030
BG0040
BG0050
BG0062
BG0070
BG0080
BG0092
BG0101
BG0113
BG0129
Male
BG00010
BG0015
BG0026
BG0036
BG0046
BG0056
BG0062
BG0074
BG0086
BG0094
BG0102
BG0113
BG01260
2
BG0033
BG0040
BG0051
BG0061
BG0070
BG0080
BG0090
BG0103
BG0115
BG01219
Not Hispanic or Latino
BG0009
BG0013
BG0024
BG0033
BG0046
BG0055
BG0063
BG0074
BG0086
BG0096
BG0100
BG0111
BG01250
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Asian
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Black or African American
BG0005
BG0011
BG0020
BG0031
BG0043
BG0050
BG0062
BG0070
BG0081
BG0092
BG0100
BG0110
BG01215
White
BG0004
BG0015
BG0026
BG0034
BG0043
BG0055
BG0062
BG0074
BG0085
BG0094
BG0103
BG0116
BG01251
More than one race
BG0001
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0122
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
6
OG0046
OG0056
OG00640
OG0074
OG0084
OG0094
OG0106
OG0116
OG01216
OG0133
OG0143
OG0153
OG0166
OG0176
OG0186
OG0199
3
OG0043
OG0052
OG0060
OG0073
OG0081
OG0092
OG0106
OG0115
OG0122
OG0133
OG0141
OG0150
OG0163
OG0173
OG0184
OG0190
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG006
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
OG007
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
OG008
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
OG009
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
OG010
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, in participants with T1DM.
OG011
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
OG012
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
OG013
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose in participants with T2DM in Period 1
OG014
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose in participants with T2DM in Period 2
OG015
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T2DM in Period 3
OG016
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T2DM
OG017
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose, in participants with T2DM
OG018
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose, in participants with T2DM
OG019
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
OG00640
OG0074
OG0084
OG0094
OG0106
OG0116
OG01216
OG0133
OG0143
OG0153
OG0166
OG0176
OG0186
OG0199
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG00510
Title
Denominators
Categories
Title
Measurements
OG0000.92(0.20 to 1.64)
OG0011.69(0.97 to 2.41)
OG0023.10(2.38 to 3.82)
OG0033.32(2.60 to 4.04)
OG0044.39(3.67 to 5.11)
OG0052.72(2.16 to 3.28)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with Type 1 diabetes mellitus
OG002
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
Units
Counts
Participants
OG0006
OG0016
OG0024
Title
Denominators
Categories
Title
Measurements
OG0001.33(0.63 to 2.04)
OG0012.74(2.03 to 3.44)
OG0022.32(1.45 to 3.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Mean
1.33
Standard Error of the Mean
0.326
2-Sided
95
0.63
2.04
Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).
Other
The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).
OG001
Mean
2.74
Standard Error of the Mean
0.326
2-Sided
95
2.03
3.44
Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).
Other
The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG002
Part 4 (T2DM) MK-1092 64 Nmol/kg SC (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG003
Part 4 (T2DM) Glargine 3.0 Nmol/kg SC (Period 1)
Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG004
Part 4 (T2DM) Glargine 3.0 Nmol/kg SC (Period 2)
Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG005
Part 4 (T2DM) Glargine 3.0 Nmol/kg SC (Period 3)
Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants with T2DM
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
OG0043
OG0053
Title
Denominators
Categories
Title
Measurements
OG0001.90(1.46 to 2.35)
OG0011.40(0.95 to 1.84)
OG0022.83(2.38 to 3.27)
OG0030.93(0.30 to 1.56)
OG0041.43(0.79 to 2.06)
OG0051.20(0.57 to 1.83)
OG001
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG002
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG00510
Title
Denominators
Categories
Title
Measurements
OG0000.49(0.00 to 0.99)
OG0010.97(0.47 to 1.47)
OG0022.02(1.52 to 2.52)
OG0031.97(1.47 to 2.47)
OG0042.87(2.37 to 3.37)
OG0051.70(1.32 to 2.09)
OG001
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
OG002
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
Units
Counts
Participants
OG0006
OG0016
OG0024
Title
Denominators
Categories
Title
Measurements
OG0000.72(0.18 to 1.27)
OG0011.92(1.38 to 2.46)
OG0021.18(0.52 to 1.85)
OG001
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG002
Part 4 (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG003
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG004
Part 1 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
OG005
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
OG0043
OG0053
Title
Denominators
Categories
Title
Measurements
OG0001.02(0.83 to 1.21)
OG0010.78(0.59 to 0.97)
OG0021.70(1.51 to 1.89)
OG0030.50(0.23 to 0.77)
OG0040.64(0.37 to 0.91)
OG0050.67(0.40 to 0.94)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
OG006
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG0000.382± 21.7
OG0010.747± 25.0
OG0021.63± 12.7
OG0032.91± 18.7
OG0046.82± 27.6
OG0050.788± 20.4
OG0063.43± 18.4
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
OG006
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0001
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG00010.6± NADatum from only one participant was available so there is no associated percent geometric coefficient of variation.
OG00117.2± 12.0
OG00237.5± 11.5
OG00376.0± 10.2
OG004161± 14.1
OG00521.5± 22.2
OG00674.9± 30.5
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
Part 3 (Type 1 Diabetes Mellitus) MK-1092 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
OG006
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0001
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG00025.6± NADatum from only one participant was available so there is no associated percent geometric coefficient of variation.
OG00135.0± 13.3
OG00233.8± 19.8
OG00332.2± 16.1
OG00431.7± 13.9
OG00533.6± 28.1
OG00635.9± 26.6
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
OG006
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG00018.00(9.00 to 18.00)
OG00112.00(4.00 to 18.00)
OG00218.00(4.0 to 24.00)
OG00318.00(9.00 to 18.00)
OG00412.00(12.00 to 18.00)
OG00515.00(9.00 to 18.00)
OG00615.04(9.00 to 18.00)
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG003
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG004
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
OG005
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
OG006
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0001
OG0016
OG0026
OG0036
OG0045
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG0006.39± NADatum from only one participant was available so there is no associated percent geometric coefficient of variation. .
OG0016.17± 29.3
OG0025.41± 28.7
OG0035.84± 16.5
OG0049.27± 71.1
OG0058.54± 23.2
OG0066.70± 31.4
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Title
Measurements
OG0001.72± 46.0
OG0011.14± 32.6
OG0023.60± 23.0
Part 4 (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
Units
Counts
Participants
OG0005
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00046.1± 34.4
OG00132.7± 48.8
OG002111± 20.7
Part 4 (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
Units
Counts
Participants
OG0005
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00055.6± 27.4
OG00145.9± 52.5
OG00240.7± 13.5
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Title
Measurements
OG00014.99(9.00 to 18.00)
OG00118.00(12.00 to 18.00)
OG00221.04(18.00 to 24.00)
Part 4 (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
Units
Counts
Participants
OG0005
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG0008.26± 39.1
OG0019.09± 20.4
OG0027.28± 30.6
OG001
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0009
OG0014
Title
Denominators
Categories
Title
Measurements
OG000115± 48.4
OG001186± 33.8
OG001
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0008
OG0013
Title
Denominators
Categories
Title
Measurements
OG0003180± 44.7
OG0014240± 93.9
Glargine 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0009
OG0014
Title
Denominators
Categories
Title
Measurements
OG0001.98(0.48 to 11.97)
OG0011.74(0.5 to 3.00)
OG001
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
Units
Counts
Participants
OG0008
OG0013
Title
Denominators
Categories
Title
Measurements
OG00018.8± 64.5
OG00115.0± 65.8
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
Units
Counts
Participants
OG0003
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00085.6± 18.0
OG00191.9± 35.1
OG002105± 33.9
OG002
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
Units
Counts
Participants
OG0002
OG0011
OG0021
Title
Denominators
Categories
Title
Measurements
OG0004960± 66.2
OG001928± NADatum from only one participant was available so there is no associated geometric coefficient of variation.
OG0028020± NADatum from only one participant was available so there is no associated geometric coefficient of variation.
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
Units
Counts
Participants
OG0003
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG0001.00(0.98 to 11.98)
OG0012.00(1.00 to 9.00)
OG0022.98(1.00 to 11.98)
OG002
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
Units
Counts
Participants
OG0002
OG0011
OG0021
Title
Denominators
Categories
Title
Measurements
OG00045.2± 53.2
OG0018.10± NADatum from only one participant was available so there is no associated geometric coefficient of variation.
OG00246.5± NAData from only one participant was available so there is no associated geometric coefficient of variation.